Hip FracturesNCT04063891
Vibration Therapy as an Intervention for Enhancing Trochanteric Hip Fracture Healing in Elderly Patients
A study testing Low-magnitude high-frequency vibration (LMHFV) in people with Hip Fractures, run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in Hong Kong.
Trial summary
Currently, there are approximately 300,000 hip fractures per year in the US with a mortality rate of 20% within 1 year. In Hong Kong, around 6,000 hip fractures occur yearly with costs approximately 52 million USD, and these numbers are projected to double by 2050. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Low-magnitude high-frequency vibration (LMHFV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteHong Kong
- Study dates
- 6 Sep 2021to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Elderly male or females aged 65 years or older
- Unilateral trochanteric hip fractures (AO classification A1-A3)
- Due to unintentional fall
- Fractures fixed with cephalomedullary nail (Gamma nail, Stryker - usual practise at our unit)
- Willing and able to comply with study protocol
Who cannot join
- Open fracture
- Bilateral fractures
- Patient with multiple injuries
- Pathological fractures e.g. tumour, infection, etc.
- History of medication or disease affecting bone metabolism such as hypo/hyperthyroidism, hypo/hyperparathyroidism, etc.
- Malignancy
- Chairbound or bedbound (unable to comply for LMHFV therapy)
- Cognitive problems e.g. dementia (unable to agree for consent)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vibration Therapy as an Intervention for Enhancing Trochanteric Hip Fracture Healing in Elderly Patients: A Randomized Double-Blinded, Placebo-Controlled Clinical Trial
Currently, there are approximately 300,000 hip fractures per year in the US with a mortality rate of 20% within 1 year. In Hong Kong, around 6,000 hip fractures occur yearly with costs approximately 52 million USD, and these numbers are projected to double by 2050.
The treatment of osteoporotic fractures is a major challenge as bone healing is delayed due to the impaired healing properties with respect to bone formation, angiogenesis and mineralization. Failure to unite results in pain, weakness, reduced mobility and fixation failure, and these complications are most common in elderly patients. Enhancement of osteoporotic fracture healing even after surgical fixation is therefore critical as a major goal in modern fracture management.
Read more
Low-magnitude high-frequency vibration (LMHFV) is a biophysical intervention that provides non-invasive, systemic mechanical stimulation and we are the first group to study its effect on fracture healing. Our previous animal studies have shown LMHFV to enhance healing from the early inflammation stage to the late phases of remodeling in osteoporotic diaphyseal fracture healing. Using our newly developed clinically relevant metaphyseal fracture model, we further proved the efficacy of LMHFV. Our results show LMHFV significantly enhanced fracture healing in both osteoporotic and normal rats radiologically by X-ray and micro-CT, histologically and biomechanically.
Justified with our preclinical studies, we hypothesize LMHFV can accelerate the time to fracture healing and enhance functional recovery. In this study, we propose to study the efficacy of LMHFV in trochanteric hip fracture healing by conducting a randomized double-blinded placebo-controlled clinical trial. Elderly patients aged 65 years or older of either gender, after surgical fixation, will be treated with LMHFV at 35Hz, 0.3g, 20 minutes/day, 5 days/week for 6 months. Results will be evaluated by clinical assessments, radiologically with X-rays, Computed Tomography (CT) and dynamic perfusion Magnetic Resonance Imaging (MRI) for blood circulation evaluation, Dual-energy X-ray absorptiometry (DXA), functional outcomes, and mortality. Positive findings from the study would have huge impact and change clinical practice.
Read the detailed description
Osteoporosis predisposes patients to increased risk of fragility fractures, which affects clinical outcomes and functional recovery. In fact, the lifetime fracture risk of osteoporotic patients reaches as high as 40%. There are approximately 2.5 million osteoporotic fractures each year in the United States (US), with costs estimated at $15 billion USD in 2010. Currently, there are approximately 300,000 hip fractures per year in the US with a mortality rate of 20% within 1 year.
Low-magnitude high-frequency vibration (LMHFV) is a promising biophysical intervention that provides non-invasive, systemic mechanical stimulation. We previously conducted a randomized controlled trial with 710 healthy, active and independent postmenopausal women over 60 years old. The LMHFV group had significant improvements in reaction time, movement velocity, maximum excursion of balancing ability assessment and also quadriceps muscle strength (p<0.001). There were significantly lower fall incidences with 18.6% of 334 vibration group subjects compared with 28.7% of 327 control group subjects (adjusted HR=0.56, p=0.001). Benefits of LMHFV for balancing ability, muscle strength and risk of falling were retained 1 year after cessation of the treatment.
This is a randomized double-blinded placebo-controlled clinical trial to investigate the use of LMHFV to enhance trochanteric hip fracture healing and will provide impactful findings for the future management of osteoporotic fractures.
Objectives
- To investigate the efficacy of LMHFV in trochanteric hip fractures on the time to radiological healing by conducting a randomized double-blinded placebo-controlled controlled clinical trial
- To assess the effects of LMHFV in trochanteric hip fractures compared with control on clinical outcomes, densitometry, blood circulation, and mortality
Research Plan and Methodology A total of 120 unilateral trochanteric hip fracture (AO classification A1-A3) patients due to unintentional fall, aged 65 years or older, will be recruited. Patients will be randomized into either vibration or placebo group after surgical fixation with a cephalomedullary nail. Radiology will be taken after fixation and regular follow-up X-rays will be taken. CTs will also be taken to assess fracture healing. Blood circulation will be assessed by dynamic perfusion MR. BMD and Bone mineral content (BMC) at fracture site will be measured by Dual X-ray Absorptiometry (DXA) scan. Clinically, vital signs, wound condition and pain intensity will be monitored. Functional outcomes including Short Form-36 (SF-36), muscle strength, Timed up and go (TUG) test and balancing ability are evaluated. Mortality will be documented. Throughout the study, complications and safety issues will be documented and in case adverse events occur, treatment will be terminated immediately. The above parameters will be compared between pre- and post-treatment and between the 2 groups.
- Conditions
- Hip Fractures
- Being tested
- Low-magnitude high-frequency vibration (LMHFV)
- Keywords
- Fracture healing, Osteoporosis, Vibration treatment
- Medical subject headings
- Hip Fractures, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-magnitude high-frequency vibration (LMHFV)Device
Low-magnitude high-frequency vibration (LMHFV) is a biophysical intervention that provides non-invasive, systemic mechanical stimulation and has been reported to have no adverse effect.
Low-magnitude high-frequency vibration (LMHFV)Device
Placebo group will have sham treatment by standing on the LMHFV platform for 20 minutes/day
| Study group | Role | What they receive |
|---|---|---|
| Placebo-Controlled | Placebo comparator | Placebo group will have placebo treatment by standing on the LMHFV platform for 20 minutes/day Receives: Device: Low-magnitude high-frequency vibration (LMHFV) |
| Vibration Group | Experimental | Vibration group is treated with LMHFV at 35Hz, 0.3g, for 20 minutes/day, 5 times/week Receives: Device: Low-magnitude high-frequency vibration (LMHFV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in time to healing
X-ray
Measured: X-ray: baseline, 12, 52 weeks post-operation
Change in time to healing
Computed Tomography
Measured: 6 weeks post-operation
Secondary outcomes (9)
Densitometry
Bone Mineral Density
Measured: baseline, 6, 12 and 26 weeks post-operation
Densitometry
Bone mineral content
Measured: baseline, 6, 12 and 26 weeks post-operation
Blood circulation at fracture site
Measured by dynamic contrast-enhanced MR imaging
Measured: 6 weeks post-operation
Pain scale
Verbal Descriptor Scale (Pain Thermometer): scale ranges from 0 to 10, higher score indicates more pain
Measured: 2, 6, 12, 16, 20, 26, 36, 52 weeks post-operation
Quality of life questionnaire (SF-36)
Functional status questionnaire to measure health-related quality of life in eight domains (physical functoning, physicial and emotional limitations, social functioning, bodily pain, general and mental health; Scores ranges from 0-100, higher score indicates better result.
Measured: 2, 6, 12, 16, 20, 26, 36, 52 weeks post-operation
Quadriceps muscle strength
Dynamometer
Measured: 2, 6, 12, 16, 20, 26, 36, 52 weeks post-operation
Balancing ability
Basic Balance Master System
Measured: 2, 6, 12, 16, 20, 26, 36, 52 weeks post-operation
Time up and go test (TUG)
The subject will stand from a chair, walk 3 meters and travel back and sit back on the chair. The time is recorded
Measured: 2, 6, 12, 16, 20, 26, 36, 52 weeks post-operation
Mortality
Measured: 1 month, 3 months and 1 year post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start6 Sep 2021
- Primary completion6 Sep 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Double-Blinded, Placebo-Controlled Clinical Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Tai Po Hospital
- Responsible party
- Principal investigator, Ronald Man Yeung WONG, Chinese University of Hong Kong
- Investigators
- Ronald Man Yeung Wong, MRCSEd, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063891
- Sponsor's protocol ID
- 2018.584
- Status last verified
- May 2025
- First submitted
- 18 Aug 2019
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rachner TD, Khosla S, Hofbauer LC. Osteoporosis: now and the future. Lancet. 2011 Apr 9;377(9773):1276-87. doi: 10.1016/S0140-6736(10)62349-5. Epub 2011 Mar 28.
PubMed 21450337Solomon DH, Patrick AR, Schousboe J, Losina E. The potential economic benefits of improved postfracture care: a cost-effectiveness analysis of a fracture liaison service in the US health-care system. J Bone Miner Res. 2014 Jul;29(7):1667-74. doi: 10.1002/jbmr.2180.
PubMed 24443384Black DM, Rosen CJ. Postmenopausal Osteoporosis. N Engl J Med. 2016 May 26;374(21):2096-7. doi: 10.1056/NEJMc1602599. No abstract available.
PubMed 27223157Shi HF, Cheung WH, Qin L, Leung AH, Leung KS. Low-magnitude high-frequency vibration treatment augments fracture healing in ovariectomy-induced osteoporotic bone. Bone. 2010 May;46(5):1299-305. doi: 10.1016/j.bone.2009.11.028. Epub 2009 Dec 2.
PubMed 19961960Bow CH, Tsang SW, Loong CH, Soong CS, Yeung SC, Kung AW. Bone mineral density enhances use of clinical risk factors in predicting ten-year risk of osteoporotic fractures in Chinese men: the Hong Kong Osteoporosis Study. Osteoporos Int. 2011 Nov;22(11):2799-807. doi: 10.1007/s00198-010-1490-0. Epub 2011 Jan 14.
PubMed 21234548Cheung WH, Sun MH, Zheng YP, Chu WC, Leung AH, Qin L, Wei FY, Leung KS. Stimulated angiogenesis for fracture healing augmented by low-magnitude, high-frequency vibration in a rat model-evaluation of pulsed-wave doppler, 3-D power Doppler ultrasonography and micro-CT microangiography. Ultrasound Med Biol. 2012 Dec;38(12):2120-9. doi: 10.1016/j.ultrasmedbio.2012.07.025. Epub 2012 Oct 11.
PubMed 23062367Leung KS, Yuen WF, Ngai WK, Lam CY, Lau TW, Lee KB, Siu KM, Tang N, Wong SH, Cheung WH. How well are we managing fragility hip fractures? A narrative report on the review with the attempt to setup a Fragility Fracture Registry in Hong Kong. Hong Kong Med J. 2017 Jun;23(3):264-71. doi: 10.12809/hkmj166124. Epub 2017 May 5.
PubMed 28473651Leung KS, Shi HF, Cheung WH, Qin L, Ng WK, Tam KF, Tang N. Low-magnitude high-frequency vibration accelerates callus formation, mineralization, and fracture healing in rats. J Orthop Res. 2009 Apr;27(4):458-65. doi: 10.1002/jor.20753.
PubMed 18924140Chung SL, Leung KS, Cheung WH. Low-magnitude high-frequency vibration enhances gene expression related to callus formation, mineralization and remodeling during osteoporotic fracture healing in rats. J Orthop Res. 2014 Dec;32(12):1572-9. doi: 10.1002/jor.22715. Epub 2014 Aug 17.
PubMed 25131218Chow DH, Leung KS, Qin L, Leung AH, Cheung WH. Low-magnitude high-frequency vibration (LMHFV) enhances bone remodeling in osteoporotic rat femoral fracture healing. J Orthop Res. 2011 May;29(5):746-52. doi: 10.1002/jor.21303. Epub 2010 Dec 23.
PubMed 21437955Wei FY, Chow SK, Leung KS, Qin J, Guo A, Yu OL, Li G, Cheung WH. Low-magnitude high-frequency vibration enhanced mesenchymal stem cell recruitment in osteoporotic fracture healing through the SDF-1/CXCR4 pathway. Eur Cell Mater. 2016 May 24;31:341-54. doi: 10.22203/ecm.v031a22.
PubMed 27215741Leung KS, Li CY, Tse YK, Choy TK, Leung PC, Hung VW, Chan SY, Leung AH, Cheung WH. Effects of 18-month low-magnitude high-frequency vibration on fall rate and fracture risks in 710 community elderly--a cluster-randomized controlled trial. Osteoporos Int. 2014 Jun;25(6):1785-95. doi: 10.1007/s00198-014-2693-6. Epub 2014 Mar 28.
PubMed 24676848Cheung WH, Li CY, Zhu TY, Leung KS. Improvement in muscle performance after one-year cessation of low-magnitude high-frequency vibration in community elderly. J Musculoskelet Neuronal Interact. 2016 Mar;16(1):4-11.
PubMed 26944817Griffith JF. Functional imaging of the musculoskeletal system. Quant Imaging Med Surg. 2015 Jun;5(3):323-31. doi: 10.3978/j.issn.2223-4292.2015.03.07.
PubMed 26029633Griffith JF, Genant HK. New imaging modalities in bone. Curr Rheumatol Rep. 2011 Jun;13(3):241-50. doi: 10.1007/s11926-011-0174-x.
PubMed 21369797
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibration Therapy as an Intervention for Enhancing Trochanteric Hip Fracture Healing in Elderly Patients: A Randomized Double-Blinded, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04063891
- Acronym / sponsor ID
- 2018.584
- Conditions
- Hip Fractures
- Keywords
- Fracture healing, Osteoporosis, Vibration treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong KongUniversity, hospital or other
- Collaborators
- Tai Po Hospital
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 6 Sep 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 21 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently, there are approximately 300,000 hip fractures per year in the US with a mortality rate of 20% within 1 year. In Hong Kong, around 6,000 hip fractures occur yearly with costs approximately 52 million USD, and these numbers are projected to double by 2050.
The treatment of osteoporotic fractures is a major challenge as bone healing is delayed due to the impaired healing properties with respect to bone formation, angiogenesis and mineralization. Failure to unite results in pain, weakness, reduced mobility and fixation failure, and these complications are most common in elderly patients. Enhancement of osteoporotic fracture healing even after surgical fixation is therefore critical as a major goal in modern fracture management.
Low-magnitude high-frequency vibration (LMHFV) is a biophysical intervention that provides non-invasive, systemic mechanical stimulation and we are the first group to study its effect on fracture healing. Our previous animal studies have shown LMHFV to enhance healing from the early inflammation stage to the late phases of remodeling in osteoporotic diaphyseal fracture healing. Using our newly developed clinically relevant metaphyseal fracture model, we further proved the efficacy of LMHFV. Our results show LMHFV significantly enhanced fracture healing in both osteoporotic and normal rats radiologically by X-ray and micro-CT, histologically and biomechanically.
Justified with our preclinical studies, we hypothesize LMHFV can accelerate the time to fracture healing and enhance functional recovery. In this study, we propose to study the efficacy of LMHFV in trochanteric hip fracture healing by conducting a randomized double-blinded placebo-controlled clinical trial. Elderly patients aged 65 years or older of either gender, after surgical fixation, will be treated with LMHFV at 35Hz, 0.3g, 20 minutes/day, 5 days/week for 6 months. Results will be evaluated by clinical assessments, radiologically with X-rays, Computed Tomography (CT) and dynamic perfusion Magnetic Resonance Imaging (MRI) for blood circulation evaluation, Dual-energy X-ray absorptiometry (DXA), functional outcomes, and mortality. Positive findings from the study would have huge impact and change clinical practice.
Detailed description
Osteoporosis predisposes patients to increased risk of fragility fractures, which affects clinical outcomes and functional recovery. In fact, the lifetime fracture risk of osteoporotic patients reaches as high as 40%. There are approximately 2.5 million osteoporotic fractures each year in the United States (US), with costs estimated at $15 billion USD in 2010. Currently, there are approximately 300,000 hip fractures per year in the US with a mortality rate of 20% within 1 year.
Low-magnitude high-frequency vibration (LMHFV) is a promising biophysical intervention that provides non-invasive, systemic mechanical stimulation. We previously conducted a randomized controlled trial with 710 healthy, active and independent postmenopausal women over 60 years old. The LMHFV group had significant improvements in reaction time, movement velocity, maximum excursion of balancing ability assessment and also quadriceps muscle strength (p<0.001). There were significantly lower fall incidences with 18.6% of 334 vibration group subjects compared with 28.7% of 327 control group subjects (adjusted HR=0.56, p=0.001). Benefits of LMHFV for balancing ability, muscle strength and risk of falling were retained 1 year after cessation of the treatment.
This is a randomized double-blinded placebo-controlled clinical trial to investigate the use of LMHFV to enhance trochanteric hip fracture healing and will provide impactful findings for the future management of osteoporotic fractures.
Objectives
- To investigate the efficacy of LMHFV in trochanteric hip fractures on the time to radiological healing by conducting a randomized double-blinded placebo-controlled controlled clinical trial
- To assess the effects of LMHFV in trochanteric hip fractures compared with control on clinical outcomes, densitometry, blood circulation, and mortality
Research Plan and Methodology A total of 120 unilateral trochanteric hip fracture (AO classification A1-A3) patients due to unintentional fall, aged 65 years or older, will be recruited. Patients will be randomized into either vibration or placebo group after surgical fixation with a cephalomedullary nail. Radiology will be taken after fixation and regular follow-up X-rays will be taken. CTs will also be taken to assess fracture healing. Blood circulation will be assessed by dynamic perfusion MR. BMD and Bone mineral content (BMC) at fracture site will be measured by Dual X-ray Absorptiometry (DXA) scan. Clinically, vital signs, wound condition and pain intensity will be monitored. Functional outcomes including Short Form-36 (SF-36), muscle strength, Timed up and go (TUG) test and balancing ability are evaluated. Mortality will be documented. Throughout the study, complications and safety issues will be documented and in case adverse events occur, treatment will be terminated immediately. The above parameters will be compared between pre- and post-treatment and between the 2 groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Double-Blinded, Placebo-Controlled Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Placebo-Controlled | Placebo comparator | Device: Low-magnitude high-frequency vibration (LMHFV)Placebo group will have placebo treatment by standing on the LMHFV platform for 20 minutes/day |
| Vibration Group | Experimental | Device: Low-magnitude high-frequency vibration (LMHFV)Vibration group is treated with LMHFV at 35Hz, 0.3g, for 20 minutes/day, 5 times/week |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Elderly male or females aged 65 years or older
- Unilateral trochanteric hip fractures (AO classification A1-A3)
- Due to unintentional fall
- Fractures fixed with cephalomedullary nail (Gamma nail, Stryker - usual practise at our unit)
- Willing and able to comply with study protocol
Key exclusion criteria (8 listed)
- Open fracture
- Bilateral fractures
- Patient with multiple injuries
- Pathological fractures e.g. tumour, infection, etc.
- History of medication or disease affecting bone metabolism such as hypo/hyperthyroidism, hypo/hyperparathyroidism, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-magnitude high-frequency vibration (LMHFV)Low-magnitude high-frequency vibration (LMHFV) is a biophysical intervention that provides non-invasive, systemic mechanical stimulation and has been reported to have no adverse effect. | Device | Vibration Group |
| Low-magnitude high-frequency vibration (LMHFV)Placebo group will have sham treatment by standing on the LMHFV platform for 20 minutes/day | Device | Placebo-Controlled |
Primary outcome
Change in time to healing
Time frame: X-ray: baseline, 12, 52 weeks post-operation
X-ray
Change in time to healing
Time frame: 6 weeks post-operation
Computed Tomography
9 secondary outcomes
Densitometry
Time frame: baseline, 6, 12 and 26 weeks post-operation
Densitometry
Time frame: baseline, 6, 12 and 26 weeks post-operation
Blood circulation at fracture site
Time frame: 6 weeks post-operation
Pain scale
Time frame: 2, 6, 12, 16, 20, 26, 36, 52 weeks post-operation
Quality of life questionnaire (SF-36)
Time frame: 2, 6, 12, 16, 20, 26, 36, 52 weeks post-operation
Quadriceps muscle strength
Time frame: 2, 6, 12, 16, 20, 26, 36, 52 weeks post-operation
Balancing ability
Time frame: 2, 6, 12, 16, 20, 26, 36, 52 weeks post-operation
Time up and go test (TUG)
Time frame: 2, 6, 12, 16, 20, 26, 36, 52 weeks post-operation
Mortality
Time frame: 1 month, 3 months and 1 year post-operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Background: PubMed 21450337Rachner TD, Khosla S, Hofbauer LC. Osteoporosis: now and the future. Lancet. 2011 Apr 9;377(9773):1276-87. doi: 10.1016/S0140-6736(10)62349-5. Epub 2011 Mar 28.
- Background: PubMed 24443384Solomon DH, Patrick AR, Schousboe J, Losina E. The potential economic benefits of improved postfracture care: a cost-effectiveness analysis of a fracture liaison service in the US health-care system. J Bone Miner Res. 2014 Jul;29(7):1667-74. doi: 10.1002/jbmr.2180.
- Background: PubMed 27223157Black DM, Rosen CJ. Postmenopausal Osteoporosis. N Engl J Med. 2016 May 26;374(21):2096-7. doi: 10.1056/NEJMc1602599. No abstract available.
- Background: PubMed 19961960Shi HF, Cheung WH, Qin L, Leung AH, Leung KS. Low-magnitude high-frequency vibration treatment augments fracture healing in ovariectomy-induced osteoporotic bone. Bone. 2010 May;46(5):1299-305. doi: 10.1016/j.bone.2009.11.028. Epub 2009 Dec 2.
- Background: PubMed 21234548Bow CH, Tsang SW, Loong CH, Soong CS, Yeung SC, Kung AW. Bone mineral density enhances use of clinical risk factors in predicting ten-year risk of osteoporotic fractures in Chinese men: the Hong Kong Osteoporosis Study. Osteoporos Int. 2011 Nov;22(11):2799-807. doi: 10.1007/s00198-010-1490-0. Epub 2011 Jan 14.
- Background: PubMed 23062367Cheung WH, Sun MH, Zheng YP, Chu WC, Leung AH, Qin L, Wei FY, Leung KS. Stimulated angiogenesis for fracture healing augmented by low-magnitude, high-frequency vibration in a rat model-evaluation of pulsed-wave doppler, 3-D power Doppler ultrasonography and micro-CT microangiography. Ultrasound Med Biol. 2012 Dec;38(12):2120-9. doi: 10.1016/j.ultrasmedbio.2012.07.025. Epub 2012 Oct 11.
- Background: PubMed 28473651Leung KS, Yuen WF, Ngai WK, Lam CY, Lau TW, Lee KB, Siu KM, Tang N, Wong SH, Cheung WH. How well are we managing fragility hip fractures? A narrative report on the review with the attempt to setup a Fragility Fracture Registry in Hong Kong. Hong Kong Med J. 2017 Jun;23(3):264-71. doi: 10.12809/hkmj166124. Epub 2017 May 5.
- Background: PubMed 18924140Leung KS, Shi HF, Cheung WH, Qin L, Ng WK, Tam KF, Tang N. Low-magnitude high-frequency vibration accelerates callus formation, mineralization, and fracture healing in rats. J Orthop Res. 2009 Apr;27(4):458-65. doi: 10.1002/jor.20753.
- Background: PubMed 25131218Chung SL, Leung KS, Cheung WH. Low-magnitude high-frequency vibration enhances gene expression related to callus formation, mineralization and remodeling during osteoporotic fracture healing in rats. J Orthop Res. 2014 Dec;32(12):1572-9. doi: 10.1002/jor.22715. Epub 2014 Aug 17.
- Background: PubMed 21437955Chow DH, Leung KS, Qin L, Leung AH, Cheung WH. Low-magnitude high-frequency vibration (LMHFV) enhances bone remodeling in osteoporotic rat femoral fracture healing. J Orthop Res. 2011 May;29(5):746-52. doi: 10.1002/jor.21303. Epub 2010 Dec 23.
- Background: PubMed 27215741Wei FY, Chow SK, Leung KS, Qin J, Guo A, Yu OL, Li G, Cheung WH. Low-magnitude high-frequency vibration enhanced mesenchymal stem cell recruitment in osteoporotic fracture healing through the SDF-1/CXCR4 pathway. Eur Cell Mater. 2016 May 24;31:341-54. doi: 10.22203/ecm.v031a22.
- Background: PubMed 24676848Leung KS, Li CY, Tse YK, Choy TK, Leung PC, Hung VW, Chan SY, Leung AH, Cheung WH. Effects of 18-month low-magnitude high-frequency vibration on fall rate and fracture risks in 710 community elderly--a cluster-randomized controlled trial. Osteoporos Int. 2014 Jun;25(6):1785-95. doi: 10.1007/s00198-014-2693-6. Epub 2014 Mar 28.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Man Yeung Wong, MRCSEd, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-magnitude high-frequency vibration (LMHFV) in people with Hip Fractures, run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in time to healing (time frame: X-ray: baseline, 12, 52 weeks post-operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04063891, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.